MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW VASONOVA VPS G4 CONSOLE/ACCESSORIES; CATHETER ULTRASOUND VASCULAR

Model Number	IPN035976
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: "a blue bullseye was obtained during a picc insertion using our vps g4 system.Approximately 2 hrs post insertion, it was reported the patient experienced heart palpitations.The patient received a chest x-ray, which read that the picc was approximately 6cm deep and needed to be pulled back." no patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#: (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Corrected data: section h.6.-type of investigation code corrected from 4114 to 10.
Event or Problem Description
The complaint is reported as: "a blue bullseye was obtained during a picc insertion using our vps g4 system.Approximately 2 hrs post insertion, it was reported the patient experienced heart palpitations.The patient received a chest x-ray, which read that the picc was approximately 6cm deep and needed to be pulled back." no patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).A vps g4 system s/n: (b)(6) with accessories was returned.A visual examination revealed the ecg cable, sec cable, and remote control exhibited normal wear while all other returned items were in acceptable condition with no obvious external defects or anomalies observed.It was reported "a blue bullseye was obtained but approximately 2 hrs post insertion a chest x-ray read the picc was approximately 6cm deep and needed to be pulled back".During functional testing using the returned cables, all steps passed, indicating the returned console was functioning as intended.Vps vascular r and d stated in a review of the case data it appeared that a blue bullseye symbol was achieved with an elevated p-wave in the ecg signal.Shortly thereafter, the case however ended with an orange symbol.In the navigation aids section of the user manual, there is a note that states 'do not end a case on either a yellow triangle or an orange circle'.This same information also appears in the manual under the troubleshooting section for an unstable symbol.At the end of the case where the orange symbol occurs, there is a negative deflection present on the p-wave in the ecg signal.The negative deflection on the p-wave suggests that the tip of the catheter/stylet is beyond the lower 1/3 of the svc.Vps vascular r & d concluded with the information available, the case was ended on an orange symbol which is not recommended by the user manual.There also appears to be a negative p-wave deflection which suggest the catheter/stylet is beyond the desired location thus, why the catheter could have been found to be placed deep.A device history record review performed on the monitor did not reveal any manufacturing or servicing related issues.The reported issue was confirmed by evaluation of returned vps g4 system.The probable cause of this issue is clinician technique.No further action will be taken.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
The complaint is reported as: "a blue bullseye was obtained during a picc insertion using our vps g4 system.Approximately 2 hrs post insertion, it was reported the patient experienced heart palpitations.The patient received a chest x-ray, which read that the picc was approximately 6cm deep and needed to be pulled back." no patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW VASONOVA VPS G4 CONSOLE/ACCESSORIES
• Common Device Name: CATHETER ULTRASOUND VASCULAR
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14274165
• Report Number: 3003898360-2022-00147
• Device Sequence Number: 20310176
• Product Code: OBJ
• UDI-Device Identifier: 30801902129230
• UDI-Public: 30801902129230
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN035976
• Device Catalogue Number: VPS-G4C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 05/31/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/31/2022; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown